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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1; PISTON SYRINGE
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BECTON DICKINSON, S.A. BD SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1; PISTON SYRINGE Back to Search Results
Catalog Number 305832
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported when using the bd syringe flu plus 0.25-1ml var dose there was foreign matter on device cannula/needle/syringe or any fluid path component.The following information was provided by the initial reporter.The customer stated: "foreign matter was found while injecting with the flu syringe.".
 
Manufacturer Narrative
H.6.Investigation: a device history record review was completed for provided lot number 2009403.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defects and all quality tests were found to be within specification.As samples were not received for this incident, twenty retained samples of the same lot number were obtained for evaluation by our quality engineer team.The retained samples were examined and no signs of foreign matter could be identified.Based on the information provided and the investigation results, a cause related to the manufacturing process could not be established for this reported incident.
 
Event Description
It was reported when using the bd syringe flu plus 0.25-1ml var dose there was foreign matter on device cannula/needle/syringe or any fluid path component.The following information was provided by the initial reporter.The customer stated: "foreign matter was found while injecting with the flu syringe.".
 
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Brand Name
BD SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP   22520
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12709762
MDR Text Key278835451
Report Number3002682307-2021-00577
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K091377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305832
Device Lot Number2009403
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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